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FDA MoCRA Cosmetic Product Listing

MoCRA requires the responsible person named on the label to list every cosmetic marketed in the U.S. with FDA, including ingredient information, and update the listing annually. We file each product on your behalf.

RegulatorU.S. FDA
PrerequisiteValid facility registration number
Submission~1-2 weeks per product
RenewalAnnual update
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What this service is

MoCRA added section 607 to the FD&C Act, requiring the "responsible person" — generally the manufacturer, packer, or distributor whose name appears on the label — to list each marketed cosmetic product with FDA, covering ingredients and manufacturing facility information.

Listings are submitted per product and must be updated annually. Products introduced after MoCRA's enactment must be listed within 120 days of first marketing in the United States. FDA charges no official fee for product listing.

MoCRA (2022)FD&C Act §607

Who needs it

Brands selling cosmetics under their own name in the U.S. whose name appears on the label
Brands whose products are entering or already on the U.S. market without a MoCRA listing
Companies whose formulas, ingredients, or facility details changed and whose existing listings need updates

Prerequisites and sequence

MoCRA Facility Registration→Cosmetic Ingredient Review→MoCRA Product Listing
  • The manufacturing facility should be registered under MoCRA first — listings must reference a valid facility registration number.
  • The responsible person must be identified for each product; the listing obligation rests with the party named on the label.
  • Formulas should be organized with standardized ingredient nomenclature (e.g., INCI names) consistent with the label ingredient declaration.

Who holds regulatory responsibility

The legal obligation to list rests with the responsible person named on the label. We organize the filing data and submit on your behalf; you are responsible for the accuracy of formula and ingredient information.

Materials we need from you

Brand name, product name, and product category for each product
Complete ingredient list per product (standardized nomenclature, in descending order)
Facility registration number(s) for each product
Responsible person's company name and contact details
Notes on special ingredients such as fragrances or flavors, where applicable

Process

  1. 01

    Inventory the products to be listed and confirm the responsible person for each

  2. 02

    Organize ingredient and facility information per product

  3. 03

    Submit each listing through FDA's electronic submission channel

  4. 04

    Obtain and archive the listing number for each product

  5. 05

    Set up the annual update cycle and change-synchronization process

Deliverables

FDA listing number for each product
Summary table of submitted listing content
Annual update and change-sync guidance

Timeline

With complete documents, each listing is typically submitted in about 1-2 weeks; larger product portfolios are filed in batches and the overall schedule extends accordingly.

Scope

What we provide

  • Product inventory and responsible-person determination
  • Standardized ingredient data preparation
  • Per-product listing submission and confirmation
  • Annual update reminders

What is not included

  • Formula adjustment or redevelopment
  • Re-listing after major formula changes (available as a separate engagement)
  • Label design and printing

What usually follows

Cosmetic Label ReviewToxicological Risk Assessment (TRA)

Common pitfalls

Identifying the wrong responsible personThe listing obligation rests with the party named on the label. For OEM brands, if the label carries the brand's name rather than the factory's, the obligation sits with the brand. Confirm the responsible person before filing.
Assuming a listing is valid permanentlyListings must be updated annually, and changes to formula, ingredients, or manufacturing facility should be reflected promptly. A stale listing drifts away from the product actually on the market.
Referencing a lapsed facility registration numberListings depend on a valid facility registration number; an expired facility registration will stall the filing. Confirm the manufacturing facility's registration is still active before listing.

Pricing

Pricing depends on your product, quantity, and target market. Submit your product details and we will come back with a defined scope and quote.

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FAQ

Who carries the listing obligation?

The "responsible person" — the manufacturer, packer, or distributor whose name appears on the product label. If you sell an OEM/ODM brand, confirm whose name is on the label first.

Is a listing valid permanently?

No. Listings must be updated annually, and changes to the formula, ingredients, or manufacturing facility should be reflected promptly.

Does FDA charge a fee for product listing?

No. FDA charges no official fee for cosmetic product listing. Service fees cover the data preparation and filing assistance.

Will submitted ingredients become public?

Listing information is managed as MoCRA provides, with special handling for ingredients such as fragrances and flavors. We confirm the filing basis with you when preparing the formula data.

Related services

MoCRA Facility RegistrationMoCRA requires facilities that manufacture or process cosmetics for the U.S. market to register with FDA and renew every two years. Foreign facilities must also designate a U.S. agent. We prepare the filing, submit it, and track renewals.Cosmetic Ingredient ReviewA clause-by-clause check of your formula under the FDA framework: prohibited and restricted ingredients, color additive rules, and standardized nomenclature (INCI). Risk ingredients are flagged, laying the groundwork for label finalization and product listing.Cosmetic Label ReviewA clause-by-clause review of your existing label against FDA cosmetic labeling rules: claims wording, ingredient declaration, mandatory statements, type size and layout. You receive an action-point list and a suggested corrected draft, reducing misbranding risk.

Disclaimer

This is a listing assistance service; FDA decides whether to accept the filing. This page is general information, not legal advice.